JPAG - PAST MEETINGS
Thursday 12th October 2017
Stability Challenges III: Assuring the stability of medicines from manufacture to use
Royal Society of Chemistry, London
Continuing our successful Stability Challenges series, this meeting is the third in the series and is aimed at providing the latest information and best practice on many aspects of stability testing. In this particular meeting the focus will be on data evaluation, discussing the estimation and prediction of shelf lives, including physical stability, and the effects of temperature and humidity excursions. Also the efficient application of stability testing according to lean laboratory principles will be explored along with MHRA views on stability requirements and GMDP expectations.
The focus of this meeting is to examine best practice during the distribution and storage of medicines, to ensure correct storage conditions are maintained and to ensure the quality of the medicine is maintained during use in the clinic or by the patient. The generation of data to support temperature excursions and to demonstrate in-use stability will be explored.
This symposium will be of special interest to those engaged in Quality Control and Quality Assurance, pharmaceutical development, regulatory affairs, storage and distribution in the Pharmaceutical Industry, NHS manufacturing units, Contract Research Organisations, consulting, academia, and anyone else concerned with the management and assessment of drug stability.
At this symposium, you will:
• Hear from individuals involved in the regulation and inspection of stability and GDP
• Learn from industry experts on scientific developments in stability study design and interpretation
• Debate practical issues for clinical trials and amorphous drug formulations
• Examine ways to improve compliance and productivity in stability testing
• Network with other professionals and exhibitors
You will leave this event with:
• Best practice and case studies from regulatory and industry experts
• Understanding of key developments, issues and strategies in drug stability
• Improve your stability laboratory compliance and efficiency
• New connections to experts and opinion leaders in this field
• Assure the stability of your medicines
Dr Paul Whiteside - Pfizer
Miles Ambler - GlaxoSmithKline
Francisco de Matos Afonso Pereira - MHRA
Dr Niels Hartvig - Novo Nordisk
Dr Samuel Kyeremateng - Abbvie
Dr Kristin Lehmkemper - Abbvie
Dr Peter O'Connell - Cuspor
Dr Klimentina Pencheva - Pfizer
Dr Garry Scrivens - Pfizer
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Delegates at a symposium held at the Royal Pharmaceutical Society